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Volumn 12, Issue 12, 2016, Pages 1469-1481

APF530 (granisetron injection extended-release) in a three-drug regimen for delayed CINV in highly emetogenic chemotherapy

(13)  Schnadig, Ian D a   Agajanian, Richy b   Dakhil, Christopher c   Gabrail, Nashat Y d   Smith, Robert E e   Taylor, Charles f   Wilks, Sharon T g   Schwartzberg, Lee S h   Cooper, William i   Mosier, Michael C j   Payne, J Yvette k   Klepper, Michael J l   Vacirca, Jeffrey L m  


Author keywords

chemotherapy induced nausea and vomiting (CINV); extended release granisetron; highly emetogenic chemotherapy (HEC)

Indexed keywords

ANTIEMETIC AGENT; ANTINEOPLASTIC AGENT; DELAYED RELEASE FORMULATION; DEXAMETHASONE; FOSAPREPITANT; GRANISETRON; MORPHOLINE DERIVATIVE; ONDANSETRON;

EID: 84969961803     PISSN: 14796694     EISSN: 17448301     Source Type: Journal    
DOI: 10.2217/fon-2016-0070     Document Type: Article
Times cited : (20)

References (38)
  • 1
    • 33749079160 scopus 로고    scopus 로고
    • Delayed nausea and vomiting continue to reduce patients' quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment
    • Bloechl-Daum B, Deuson RR, Mavros P, Hansen M, Herrstedt J. Delayed nausea and vomiting continue to reduce patients' quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment. J. Clin. Oncol. 24(27), 4472-4478 (2006).
    • (2006) J. Clin. Oncol. , vol.24 , Issue.27 , pp. 4472-4478
    • Bloechl-Daum, B.1    Deuson, R.R.2    Mavros, P.3    Hansen, M.4    Herrstedt, J.5
  • 2
    • 80755126820 scopus 로고    scopus 로고
    • Antiemetics: American Society of Clinical Oncology clinical practice guideline update
    • Basch E, Prestrud AA, Hesketh PJ et al. Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J. Clin. Oncol. 29(31), 4189-4198 (2011).
    • (2011) J. Clin. Oncol. , vol.29 , Issue.31 , pp. 4189-4198
    • Basch, E.1    Prestrud, A.A.2    Hesketh, P.J.3
  • 3
    • 84864956209 scopus 로고    scopus 로고
    • The effect of guideline-consistent antiemetic therapy on chemotherapy-induced nausea and vomiting (CINV): The Pan European Emesis Registry (PEER)
    • Aapro M, Molassiotis A, Dicato M et al. The effect of guideline-consistent antiemetic therapy on chemotherapy-induced nausea and vomiting (CINV): The Pan European Emesis Registry (PEER). Ann. Oncol. 23(8), 1986-1992 (2012).
    • (2012) Ann. Oncol. , vol.23 , Issue.8 , pp. 1986-1992
    • Aapro, M.1    Molassiotis, A.2    Dicato, M.3
  • 5
    • 14544288652 scopus 로고    scopus 로고
    • Should 5-hydroxytryptamine-3 receptor antagonists be administered beyond 24 h after chemotherapy to prevent delayed emesis? Systematic re-evaluation of clinical evidence and drug cost implications
    • Geling O, Eichler HG. Should 5-hydroxytryptamine-3 receptor antagonists be administered beyond 24 h after chemotherapy to prevent delayed emesis? Systematic re-evaluation of clinical evidence and drug cost implications. J. Clin. Oncol. 23(6), 1289-1294 (2005).
    • (2005) J. Clin. Oncol. , vol.23 , Issue.6 , pp. 1289-1294
    • Geling, O.1    Eichler, H.G.2
  • 6
    • 77954319603 scopus 로고    scopus 로고
    • Guideline update for MASCC and ESMO in the prevention of chemotherapy-and radiotherapyinduced nausea and vomiting: Results of the Perugia consensus conference
    • Roila F, Herrstedt J, Aapro M et al. Guideline update for MASCC and ESMO in the prevention of chemotherapy-and radiotherapyinduced nausea and vomiting: results of the Perugia consensus conference. Ann. Oncol. 21(Suppl. 5), v232-v243 (2010).
    • (2010) Ann. Oncol. , vol.21 , pp. v232-v243
    • Roila, F.1    Herrstedt, J.2    Aapro, M.3
  • 8
    • 58749100277 scopus 로고    scopus 로고
    • Palonosetron plus dexamethasone versus granisetron plus dexamethasone for prevention of nausea and vomiting during chemotherapy: A doubleblind, double-dummy, randomised, comparative Phase III trial
    • Saito M, Aogi K, Sekine I et al. Palonosetron plus dexamethasone versus granisetron plus dexamethasone for prevention of nausea and vomiting during chemotherapy: A doubleblind, double-dummy, randomised, comparative Phase III trial. Lancet Oncol. 10(2), 115-124 (2009).
    • (2009) Lancet Oncol. , vol.10 , Issue.2 , pp. 115-124
    • Saito, M.1    Aogi, K.2    Sekine, I.3
  • 9
    • 33748749890 scopus 로고    scopus 로고
    • A Phase III, double-blind, randomized trial of palonosetron compared with ondansetron in preventing chemotherapyinduced nausea and vomiting following highly emetogenic chemotherapy
    • Aapro MS, Grunberg SM, Manikhas GM et al. A Phase III, double-blind, randomized trial of palonosetron compared with ondansetron in preventing chemotherapyinduced nausea and vomiting following highly emetogenic chemotherapy. Ann. Oncol. 17(9), 1441-1449 (2006).
    • (2006) Ann. Oncol. , vol.17 , Issue.9 , pp. 1441-1449
    • Aapro, M.S.1    Grunberg, S.M.2    Manikhas, G.M.3
  • 10
    • 0344412945 scopus 로고    scopus 로고
    • Improved prevention of moderately emetogenic chemotherapy-induced nausea and vomiting with palonosetron, a pharmacologically novel 5-HT3 receptor antagonist: Results of a Phase III, single-dose trial versus dolasetron
    • Eisenberg P, Figueroa-Vadillo J, Zamora R et al. Improved prevention of moderately emetogenic chemotherapy-induced nausea and vomiting with palonosetron, a pharmacologically novel 5-HT3 receptor antagonist: results of a Phase III, single-dose trial versus dolasetron. Cancer 98(11), 2473-2482 (2003).
    • (2003) Cancer , vol.98 , Issue.11 , pp. 2473-2482
    • Eisenberg, P.1    Figueroa-Vadillo, J.2    Zamora, R.3
  • 11
    • 10744219621 scopus 로고    scopus 로고
    • Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: Results of a double-blind randomized Phase III trial comparing single doses of palonosetron with ondansetron
    • Gralla R, Lichinitser M, Van DV et al. Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: results of a double-blind randomized Phase III trial comparing single doses of palonosetron with ondansetron. Ann. Oncol. 14(10), 1570-1577 (2003).
    • (2003) Ann. Oncol. , vol.14 , Issue.10 , pp. 1570-1577
    • Gralla, R.1    Lichinitser, M.2    Van, D.V.3
  • 12
    • 84940422769 scopus 로고    scopus 로고
    • Palonosetron or granisetron for prevention of CINV in patients with breast cancer receiving dexamethasone and fosaprepitant following anthracycline plus cyclophosphamide (AC) regimen
    • Abstract 9598
    • Matsumoto K, Takahashi M, Sato K et al. Palonosetron or granisetron for prevention of CINV in patients with breast cancer receiving dexamethasone and fosaprepitant following anthracycline plus cyclophosphamide (AC) regimen. J. Clin. Oncol. 33(Suppl.), Abstract 9598 (2015).
    • (2015) J. Clin. Oncol. , vol.33
    • Matsumoto, K.1    Takahashi, M.2    Sato, K.3
  • 13
    • 84922451037 scopus 로고    scopus 로고
    • Palonosetron (PALO) versus granisetron (GRA) in the triplet regimen with dexamethasone (DEX) and aprepitant (APR) for preventing chemotherapy-induced nausea and vomiting (CINV) in patients (pts) receiving highly emetogenic chemotherapy (HEC) with cisplatin (CDDP): A randomized, double-blind, Phase III trial
    • Abstract 9621
    • Hashimoto H, Yamanaka T, Shimada Y et al. Palonosetron (PALO) versus granisetron (GRA) in the triplet regimen with dexamethasone (DEX) and aprepitant (APR) for preventing chemotherapy-induced nausea and vomiting (CINV) in patients (pts) receiving highly emetogenic chemotherapy (HEC) with cisplatin (CDDP): A randomized, double-blind, Phase III trial. J. Clin. Oncol. 31(Suppl.), Abstract 9621 (2013).
    • (2013) J. Clin. Oncol. , vol.31
    • Hashimoto, H.1    Yamanaka, T.2    Shimada, Y.3
  • 14
    • 85000163465 scopus 로고    scopus 로고
    • Biochronomer™ technology and the development of APF530, a sustained release formulation of granisetron
    • Ottoboni T, Gelder M, O'Boyle E. Biochronomer™ technology and the development of APF530, a sustained release formulation of granisetron. J. Exp. Pharmacol. 6, 15-21 (2014).
    • (2014) J. Exp. Pharmacol. , vol.6 , pp. 15-21
    • Ottoboni, T.1    Gelder, M.2    O'Boyle, E.3
  • 16
    • 84969968822 scopus 로고    scopus 로고
    • Phase 1 bioavailability study comparing 2 different subcutaneous routes of administration for APF530
    • Abstract 11-16-P
    • Morrison D, Anderson A, Slama M et al. Phase 1 bioavailability study comparing 2 different subcutaneous routes of administration for APF530. Support. Care Cancer 23(Suppl.), Abstract 11-16-P (2015).
    • (2015) Support. Care Cancer , vol.23
    • Morrison, D.1    Anderson, A.2    Slama, M.3
  • 17
    • 84936972898 scopus 로고    scopus 로고
    • Pharmacokinetics, safety, and efficacy of APF530 (extended-release granisetron) in patients receiving moderately or highly emetogenic chemotherapy: Results of two Phase 2 trials
    • Gabrail N, Yanagihara R, Spaczynski M et al. Pharmacokinetics, safety, and efficacy of APF530 (extended-release granisetron) in patients receiving moderately or highly emetogenic chemotherapy: results of two Phase 2 trials. Cancer Manag. Res. 7, 83-92 (2015).
    • (2015) Cancer Manag. Res. , vol.7 , pp. 83-92
    • Gabrail, N.1    Yanagihara, R.2    Spaczynski, M.3
  • 18
    • 84942892640 scopus 로고    scopus 로고
    • Slow-release granisetron (APF530) vs palonosetron for chemotherapyinduced nausea/vomiting: Analysis by ASCO emetogenicity criteria
    • Raftopoulos H, Boccia R, Cooper B, O'Boyle E, Gralla R. Slow-release granisetron (APF530) vs palonosetron for chemotherapyinduced nausea/vomiting: analysis by ASCO emetogenicity criteria. Future Oncol. 11(18), 2541-2551 (2015).
    • (2015) Future Oncol. , vol.11 , Issue.18 , pp. 2541-2551
    • Raftopoulos, H.1    Boccia, R.2    Cooper, B.3    O'Boyle, E.4    Gralla, R.5
  • 19
    • 84922268387 scopus 로고    scopus 로고
    • Comparison of an extended-release formulation of granisetron (APF530) versus palonosetron for the prevention of chemotherapy-induced nausea and vomiting associated with moderately or highly emetogenic chemotherapy: Results of a prospective, randomized, double-blind, noninferiority Phase 3 trial
    • Raftopoulos H, Cooper W, O'Boyle E, Gabrail N, Boccia R, Gralla RJ. Comparison of an extended-release formulation of granisetron (APF530) versus palonosetron for the prevention of chemotherapy-induced nausea and vomiting associated with moderately or highly emetogenic chemotherapy: results of a prospective, randomized, double-blind, noninferiority Phase 3 trial. Support. Care Cancer 23, 723-732 (2015).
    • (2015) Support. Care Cancer , vol.23 , pp. 723-732
    • Raftopoulos, H.1    Cooper, W.2    O'Boyle, E.3    Gabrail, N.4    Boccia, R.5    Gralla, R.J.6
  • 20
    • 84942904329 scopus 로고    scopus 로고
    • Sustained antiemetic responses with APF530 (sustainedrelease granisetron) during multiple cycles of emetogenic chemotherapy
    • Boccia RV, Cooper W, O'Boyle E. Sustained antiemetic responses with APF530 (sustainedrelease granisetron) during multiple cycles of emetogenic chemotherapy. J. Commun. Support. Oncol. 13, 38-46 (2015).
    • (2015) J. Commun. Support. Oncol. , vol.13 , pp. 38-46
    • Boccia, R.V.1    Cooper, W.2    O'Boyle, E.3
  • 23
    • 0038728753 scopus 로고    scopus 로고
    • Addition of the neurokinin 1 receptor antagonist aprepitant to standard antiemetic therapy improves control of chemotherapy-induced nausea and vomiting. Results from a randomized, double-blind, placebo-controlled trial in Latin America
    • Poli-Bigelli S, Rodrigues-Pereira J, Carides AD et al. Addition of the neurokinin 1 receptor antagonist aprepitant to standard antiemetic therapy improves control of chemotherapy-induced nausea and vomiting. Results from a randomized, double-blind, placebo-controlled trial in Latin America. Cancer 97(12), 3090-3098 (2003).
    • (2003) Cancer , vol.97 , Issue.12 , pp. 3090-3098
    • Poli-Bigelli, S.1    Rodrigues-Pereira, J.2    Carides, A.D.3
  • 24
    • 33645762226 scopus 로고
    • A sharper Bonferroni procedure for multiple tests of significance
    • Hochberg Y. A sharper Bonferroni procedure for multiple tests of significance. Biometrika 75(4), 800-802 (1988).
    • (1988) Biometrika , vol.75 , Issue.4 , pp. 800-802
    • Hochberg, Y.1
  • 25
    • 84903748621 scopus 로고    scopus 로고
    • A randomized Phase III study evaluating the efficacy and safety of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy
    • Aapro M, Rugo H, Rossi G et al. A randomized Phase III study evaluating the efficacy and safety of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy. Ann. Oncol. 25(7), 1328-1333 (2014).
    • (2014) Ann. Oncol. , vol.25 , Issue.7 , pp. 1328-1333
    • Aapro, M.1    Rugo, H.2    Rossi, G.3
  • 26
    • 84906826692 scopus 로고    scopus 로고
    • Efficacy of a triple antiemetic regimen with aprepitant for the prevention of chemotherapy-induced nausea and vomiting: Effects of gender, age, and region
    • Rapoport BL. Efficacy of a triple antiemetic regimen with aprepitant for the prevention of chemotherapy-induced nausea and vomiting: effects of gender, age, and region. Curr. Med. Res. Opin. 30(9), 1875-1881 (2014).
    • (2014) Curr. Med. Res. Opin. , vol.30 , Issue.9 , pp. 1875-1881
    • Rapoport, B.L.1
  • 27
    • 84903748544 scopus 로고    scopus 로고
    • Efficacy and safety of NEPA, an oral combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy: A randomized dose-ranging pivotal study
    • Hesketh PJ, Rossi G, Rizzi G et al. Efficacy and safety of NEPA, an oral combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy: A randomized dose-ranging pivotal study. Ann. Oncol. 25(7), 1340-1346 (2014).
    • (2014) Ann. Oncol. , vol.25 , Issue.7 , pp. 1340-1346
    • Hesketh, P.J.1    Rossi, G.2    Rizzi, G.3
  • 28
    • 77952480785 scopus 로고    scopus 로고
    • Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: A randomized, double-blind study
    • Rapoport BL, Jordan K, Boice JA et al. Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: A randomized, double-blind study. Support. Care Cancer 18(4), 423-431 (2010).
    • (2010) Support. Care Cancer , vol.18 , Issue.4 , pp. 423-431
    • Rapoport, B.L.1    Jordan, K.2    Boice, J.A.3
  • 29
    • 84940596145 scopus 로고    scopus 로고
    • Safety and efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of cisplatin-based highly emetogenic chemotherapy in patients with cancer: Two randomised, active-controlled, double-blind, Phase 3 trials
    • Rapoport BL, Chasen MR, Gridelli C et al. Safety and efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of cisplatin-based highly emetogenic chemotherapy in patients with cancer: two randomised, active-controlled, double-blind, Phase 3 trials. Lancet Oncol. 16(9), 1079-1089 (2015).
    • (2015) Lancet Oncol. , vol.16 , Issue.9 , pp. 1079-1089
    • Rapoport, B.L.1    Chasen, M.R.2    Gridelli, C.3
  • 30
    • 64949104350 scopus 로고    scopus 로고
    • Pharmacological management of chemotherapy-induced nausea and vomiting: Focus on recent developments
    • Navari RM. Pharmacological management of chemotherapy-induced nausea and vomiting: focus on recent developments. Drugs 69(5), 515-533 (2009).
    • (2009) Drugs , vol.69 , Issue.5 , pp. 515-533
    • Navari, R.M.1
  • 32
    • 84938062518 scopus 로고    scopus 로고
    • Phase 3 trial results for rolapitant, a novel NK-1 receptor antagonist, in the prevention of chemotherapy-induced nausea and vomiting (CINV) in subjects receiving moderately emetogenic chemotherapy (MEC)
    • Abstract 9633
    • Schnadig I, Modiano MR, Poma A, Hedley ML, Martell RE, Schwartzberg LS. Phase 3 trial results for rolapitant, a novel NK-1 receptor antagonist, in the prevention of chemotherapy-induced nausea and vomiting (CINV) in subjects receiving moderately emetogenic chemotherapy (MEC). J. Clin. Oncol. 32(Suppl.), Abstract 9633 (2014).
    • (2014) J. Clin. Oncol. , vol.32
    • Schnadig, I.1    Modiano, M.R.2    Poma, A.3    Hedley, M.L.4    Martell, R.E.5    Schwartzberg, L.S.6
  • 36
    • 84952873282 scopus 로고    scopus 로고
    • Difference in the emetic control among highly emetogenic chemotherapy regimens: Implementation for appropriate use of aprepitant
    • Aoki S, Iihara H, Nishigaki M et al. Difference in the emetic control among highly emetogenic chemotherapy regimens: Implementation for appropriate use of aprepitant. Mol. Clin. Oncol. 1(1), 41-46 (2013).
    • (2013) Mol. Clin. Oncol. , vol.1 , Issue.1 , pp. 41-46
    • Aoki, S.1    Iihara, H.2    Nishigaki, M.3
  • 37
    • 80051599358 scopus 로고    scopus 로고
    • Palonosetron plus 3-day aprepitant and dexamethasone to prevent nausea and vomiting in patients receiving highly emetogenic chemotherapy
    • Longo F, Mansueto G, Lapadula V et al. Palonosetron plus 3-day aprepitant and dexamethasone to prevent nausea and vomiting in patients receiving highly emetogenic chemotherapy. Support. Care Cancer 19(8), 1159-1164 (2011).
    • (2011) Support. Care Cancer , vol.19 , Issue.8 , pp. 1159-1164
    • Longo, F.1    Mansueto, G.2    Lapadula, V.3
  • 38
    • 84952874652 scopus 로고    scopus 로고
    • Efficacy and safety of olanzapine combined with aprepitant, palonosetron, and dexamethasone for preventing nausea and vomiting induced by cisplatin-based chemotherapy in gynecological cancer: KCOG-G1301 Phase II trial
    • Abe M, Hirashima Y, Kasamatsu Y et al. Efficacy and safety of olanzapine combined with aprepitant, palonosetron, and dexamethasone for preventing nausea and vomiting induced by cisplatin-based chemotherapy in gynecological cancer: KCOG-G1301 Phase II trial. Support. Care Cancer 24(2), 675-682 (2015).
    • (2015) Support. Care Cancer , vol.24 , Issue.2 , pp. 675-682
    • Abe, M.1    Hirashima, Y.2    Kasamatsu, Y.3


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